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RAPS: New FDA Guidance Addresses Common Issues in Orphan Drug Development

04.09.2015
The US Food and Drug Administration (FDA) has released a draft guidance intended to help drugmakers tackle common issues encountered in the development of drugs to treat rare diseases.
The source of the news: http://www.raps.org/Regulatory-Focus/News/2015/08/17/23015/New-FDA-Guidance-Addresses-Common-Issues-in-Orphan-Drug-Development/